MECLIZINE HYDROCHLORIDE
- Product NDC
- 0615-8515
- 11-digit product format
- 006158515
- Labeler code
- 0615
- Product ID
- 0615-8515_7c702061-6604-4b46-b035-dd0fb4d25165
- Type
- HUMAN PRESCRIPTION DRUG
- Nonproprietary name
- MECLIZINE
- Dosage form
- TABLET
- Route
- ORAL
- Labeler
- NCS HealthCare of KY, LLC dba Vangard Labs
- Application
- ANDA202640
- Marketing category
- ANDA
- Marketing start
- 2023-09-14
- Substance
- MECLIZINE HYDROCHLORIDE
- Active strength
- 25 mg/1
- Pharmacologic classes
- Antiemetic [EPC], Emesis Suppression [PE]
- NDC exclude flag
- No
- Listing certified through
- 2026-12-31
- Current FDA listing
- Yes
Additional Listing Data#
- Finished product
- Yes
- Brand name base
- MECLIZINE HYDROCHLORIDE
- Listing expiration
- 2026-12-31
Active Ingredients#
Ingredient, Strength table| Ingredient | Strength |
|---|
| MECLIZINE HYDROCHLORIDE | 25 mg/1 |
Harmonized Identifiers#
Field, Values table| Field | Values |
|---|
| Unii | HDP7W44CIO |
| Rxcui | 995624, 995666 |
DailyMed Product Concepts#
DailyMed Package Descriptions#
Package NDC, Product, Description table| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|
| 0615-8515-39 | MECLIZINE HYDROCHLORIDE | 30 in 1 BLISTER PACK | TABLET | 30 | | 1 |
DailyMed Dashboard NDC Coverage#
NDC, Dashboard title, SPL version table| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|
| 0615-8515 | MECLIZINE HYDROCHLORIDE (MECLIZINE) TABLET [NCS HEALTHCARE OF KY, LLC DBA VANGARD LABS] | 1 | Current NDC, 1 package rows | 20240810_1a33dec1-8d59-48bd-aaef-77d162194d57.zip |
DailyMed RxNorm Mappings#
Packages#
Package NDC, 11-digit format, Description table| Package NDC | 11-digit format | Description | Units | Marketing start | Sample | Exclude flag | Status |
|---|
| 0615-8515-39 | 00615851539 | 30 TABLET in 1 BLISTER PACK (0615-8515-39) | 30 tablet | 2024-07-16 | No | No | Current |